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Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations

Primary Purpose

Overweight or Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control diet
Nutriprecision diet
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight or Obesity focused on measuring Obesity, Health status, Insulin resistance, Hypertension, Lipid profile, Gastrointestinal health, Cognitive capacity, Life quality, Healthy ageing, Lifestyle intervention, Precision nutrition, Mediterranean diet, Eating behaviour, Physical activity, Oxidative stress, Inflammation, Functional ability, Nutrition education

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women aged 50-80 years
  • BMI >27 kg/m2
  • One or more of the following risk factors:

    • Glucose ≥100 to ≤125 mg/dL or type 2 diabetes (independently of antidiabetic medication)
    • Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg or under antihypertensive medication)
    • LDL-cholesterol ≥160 mg/dL independently of lipid-lowering therapy
    • HDL-cholesterol ≤40 mg/dL (men)/≤50 mg/dL (women), independently of lipid-lowering therapy
    • Triglycerides ≥160 mg/dL independently of lipid-lowering therapy
    • Waist Circumference ˃95 cm (men)/>82 cm (women), independently of lipid-lowering therapy
    • Sedentary behavior (AHA)*

Exclusion Criteria:

  • Relevant functional or structural digestive abnormalities (malformations, angiodysplasia, active peptic ulcers, chronic inflammatory diseases, or malabsorption)
  • Endocrine disorders (hyperthyroidism or uncontrolled hypothyroidism)
  • Undergone surgical interventions with permanent sequelae (gastroduodenostomy)
  • Pharmacological treatments with immunosuppressants, cytotoxic agents, systemic corticosteroids, or other drugs that could potentially cause hepatic steatosis or alteration of liver tests
  • Active cancer in the last five years or under therapy
  • Weight loss ≥3 kg in the last three months
  • Instable drug therapy in the last three months
  • Severe psychiatric disorders
  • No autonomy
  • Inability to follow the diet (food allergies, intolerances)
  • Difficulties to follow scheduled visits

    • AHA Recommendations for Physical Activity in Adults: at least 150 minutes per week of moderate-intensity aerobic activity or 75 minutes per week of vigorous aerobic activity, or a combination of both, preferably spread throughout the week.

Sites / Locations

  • Centre for Nutrition Research, University of Navarra

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control diet

Nutriprecision diet

Arm Description

A conventional diet based on the current Spanish Mediterranean dietary guidelines: Spanish Society of Community Nutrition (SENC).

A Mediterranean, balanced diet based on the inclusion of precision foods designed and developed within the framework of Nutriprecision project. A mobile application to empower and support the management of the dietary prescription. A digital tool for cognitive stimulation.

Outcomes

Primary Outcome Measures

Change From Baseline General Health Status at 3 Months
General health score encompassed twelve parameters, on a scale of 0 to 21, with higher scores indicating a worse overall health: BMI Waist Circumference Glycosylated hemoglobin (HbA1C) Total cholesterol HDL-cholesterol LDL-cholesterol Triglycerides Uric acid Systolic Blood Pressure | Diastolic Blood Pressure Gastrointestinal Health (GSRT) Cognitive Function Extra negative point if reducing medication

Secondary Outcome Measures

Change From Baseline Weight at 3 Months
Weight was measured by a digital scale
Baseline height
Height was recorded using a wall-mounted stadiometer (Seca 220, Vogel & Halke, Germany).
Change From Baseline Body Mass Index at 3 Months
Body mass index was calculated using the standard formula: weight (kg)/height (m)2
Change From Baseline Fat Mass at 3 Months
Fat mass was measured by Bioelectrical impedance analysis (BIA, SC-330, Tanita)
Change From Baseline Lean Mass at 3 Months
Lean mass was measured by Bioelectrical impedance analysis (BIA, SC-330, Tanita)
Change From Baseline Waist Circumference at 3 Months
Waist Circumference was measured by with a tape measure
Change From Baseline Hip Circumference at 3 Months
Hip Circumference was measured by with a tape measure
Change From Baseline Systolic Blood Pressure at 3 Months
Systolic Blood Pressure was measured using an automatic monitor device (Intelli Sense. M6, OMRON Healthcare, Hoofdorp, the Netherlands)
Change From Baseline Diastolic Blood Pressure at 3 Months
Diastolic Blood Pressure was measured using an automatic monitor device (Intelli Sense. M6, OMRON Healthcare, Hoofdorp, the Netherlands)
Change From Baseline Serum Triglycerides at 3 Months
Triglycerides were measured in fasting conditions
Change From Baseline Serum Total Cholesterol at 3 Months
Total cholesterol was measured in fasting conditions
Change From Baseline Serum LDL-Cholesterol at 3 Months
LDL-cholesterol was measured in fasting conditions
Change From Baseline Serum HDL-Cholesterol at 3 Months
HDL-cholesterol was measured in fasting conditions
Change From Baseline Serum Uric Acid at 3 Months
Uric acid was measured in fasting conditions
Change From Baseline Serum Glucose at 3 Months
Glucose was measured in fasting conditions
Change From Baseline Serum Insulin at 3 Months
Insulin was measured in fasting conditions
Change From Baseline Serum Glycosylated hemoglobin (HbA1C) at 3 Months
Glycosylated hemoglobin (HbA1C) was measured in fasting conditions
Change From Baseline Serum Aspartate Aminotransferase at 3 Months
Aspartate aminotransferase was measured in fasting conditions
Change From Baseline Serum Alanine Aminotransferase at 3 Months
Alanine aminotransferase was measured in fasting conditions
Change From Baseline Serum Gamma-glutamyltransferase at 3 Months
Gamma glutamyltransferase was measured in fasting conditions
Change From Baseline Physical Activity Level at 3 Months
Physical activity was measured by the International Physical Activity Questionnaire (IPAQ)
Change From Baseline Dietary Intake at 3 Months
Dietary intake was measured by a 7-day recall
Change From Baseline Mediterranean Diet Adherence at 3 Months
Mediterranean diet adherence was measured by the 14-Item Mediterranean Diet Assessment Tool
Change From Baseline Health Status at 3 Months
Health status was measured by the SF-36 Health Survey
Change From Baseline Gastrointestinal Symptoms at 3 Months
Gastrointestinal symptoms were measured by the gastrointestinal symptoms rating scale, GSRT
Change From Baseline Sensory Perception of Precision Foods at 3 Months
Sensory perception of precision foods was measured by the sensory perception questionnaire
Food Consumption of the Precision Foods
Food consumption of the precision foods was measured by a food consumption record
Change From Baseline Risk of Malnutrition at 3 Months
Risk of malnutrition was measured by the Mini Nutritional Assessment (MNA) questionnaire
Change From Baseline Cognitive Impairment at 3 Months
Cognitive impairment was measured by the Mini-Mental State Examination (MMSE) questionnaire
Change From Baseline Cognitive Function at 3 Months
Cognitive function was measured by the Guttmann NeuroPersonalTrainer platform
Baseline Gut Microbiota Composition
Gut Microbiota Composition will be measured using OMNIgene.GUT kits from DNA Genotek
Usability of the digital tools
Usability will be measured using the System Usability Scale (SUS)
Baseline subjective hunger
Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification of the perceived hunger before the experimental food intake
Postprandial subjective hunger
Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification of the perceived hunger measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Baseline subjective fullness
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before the experimental food intake
Postprandial subjective fullness
Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification of the perceived fullness measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Baseline subjective satiety
Visual analogue scale rating in a scale from 0 to100 mm for the quantification of the perceived satiety before the experimental food intake.
Postprandial subjective satiety
Visual analogue scale rating in a scale from 0 to100 mm for the quantification of the perceived satiety measured at 15, 30, 45, 60, 90 and 120 minutes after experimental food intake
Baseline subjective desire to eat
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived desire to eat before the experimental food intake at baseline.
Postprandial subjective desire to eat
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived desire to eat measured at 15, 30, 45, 60, 90 and 120 minutes after experimental food intake
Baseline subjective thirst
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived thirst before the experimental food intake at baseline
Postprandial subjective thirst
Visual analogue scale ratings in a scale from 0 to 100 mm for the quantification the perceived thirst measured at 15, 30, 45, 60, 90 and 120 minutes after experimental food intake
Baseline blood glucose concentration
Blood glucose concentration before experimental food intake
Baseline blood insulin concentration
Blood insulin concentration before experimental food intake
Incremental area under the curve (iAUC) for glucose
The incremental area under the curve (AUCi) for glucose was calculated via the geometric sums of the areas of the triangles and trapezoids above the fasting glucose concentration over a 2-h period
Incremental area under the curve (iAUC) for insulin
The incremental area under the curve (AUCi) for insulin was calculated via the geometric sums of the areas of the triangles and trapezoids above the fasting insulin concentration over a 2-h period
Baseline blood high density lipoprotein cholesterol (HDL) concentration
Blood high density lipoprotein cholesterol (HDL) concentration before experimental food intake
Baseline blood low density lipoprotein cholesterol (LDL) concentration
Blood low density lipoprotein cholesterol (LDL) concentration before experimental food intake
Baseline blood triglyceride concentration
Blood triglyceride concentration before experimental food intake
Postprandial blood glucose concentration
Blood glucose concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Postprandial blood insulin concentration
Blood insulin concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Postprandial blood total cholesterol concentration
Blood total cholesterol concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Postprandial blood high density lipoprotein cholesterol (HDL) concentration
Blood high density lipoprotein cholesterol (HDL) concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Postprandial blood low density lipoprotein cholesterol (LDL) concentration
Blood low density lipoprotein cholesterol (LDL) concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Postprandial blood triglyceride concentration
Blood triglyceride concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake

Full Information

First Posted
March 3, 2021
Last Updated
March 3, 2021
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT04786925
Brief Title
Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations
Official Title
Strategies for Improving the Quality of Life of Pre-senior and Senior Populations Based on Precision Nutrition (Proyecto Nutriprecisión)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
December 23, 2020 (Actual)
Study Completion Date
December 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The number and proportion of people aged 60 years old and over is increasing worldwide. Ageing is characterized by a progressive loss of physiological integrity, leading to impaired function and increased vulnerability to death. This deterioration is the primary risk factor for major chronic diseases including diabetes, cardiovascular disease, and neurodegenerative disorders. The incidence of chronic conditions frequently rises sharply with age, after long exposure to unhealthful lifestyles involving the consumption of unhealthy diets and physical inactivity. Consequently, integrated dietary strategies and actions are required to promote healthy ageing and target major causes of morbidity and mortality in senior populations. The promising field of precision nutrition is rising as a therapeutic approach that aims to design tailored dietary interventions to prevent and manage chronic diseases. Indeed, precision nutrition approaches contemplate the interindividual heterogeneity caused by genetic/epigenetic dissimilarities, individual facets such as age and gender, the lifestyle and environmental exposome diversity, microbiome variations, and singular behavioral/psychological features. On the other hand, the inclusion of potentially bioactive compounds and functional foods as promoters of healthy aging within personalised dietary patterns could be an effective strategy to delay the aging process and age-related chronic diseases. One of the main limitations of a dietary prescription is the lack of compliance, due to the complexity of the prescription itself and/or the lack of commitment of the individual. The inclusion of digital tools to empower and motivate individuals and to support them in the management of the dietary strategy could overcome this limitation. With this background, the general objective of this investigation is to design precision nutritional strategies based on the inclusion of functional foods and digital tools for preventing age-related chronic diseases in pre-senior and senior populations. Additionally, this study proposes alternative tools for cognitive assessments increasing the accessibility to cognitive assessment tools for this population as well as an innovative digital tool for cognitive stimulation which is personalized, monitored, and evidence-based.
Detailed Description
This study is designed as a 12-week, randomized parallel intervention trial, with two arms: 1) Control group, who follows a control diet based on the current dietary guidelines of the Spanish Society of Community Nutrition (SENC) using the Healthy Eating Plate method (Harvard), and 2) Nutriprecision Group, which were instructed to follow the Nutriprecision diet based on the inclusion of digital tools and functional foods, whose postprandial effects were previously evaluated by randomized, cross-over, double-blind studies in senior subjects in the Centre for Nutrition Research (UNAV) and IMDEA-ALIMENTACIÓN. The incremental area under the curve (iAUC) for glucose and insulin was calculated for all designed foods and was compared with their reference products. Additionally, lipid profile and satiety were measured at fasting and at 15, 30, 45, 60, 90, and 120 min after starting the food intake. In all these studies, the reference and test foods were administered once in random order, with a wash-out period between 7 days and 14 days among assays. This multi-centric study was carried out in the Nutrition Intervention Unit of the Centre for Nutrition Research in the University of Navarra and the Nutritional and Clinical Trials Unit in IMDEA-ALIMENTACIÓN by qualified professionals (nurse, doctor-dietician, dieticians, pharmacists). A total of five visits had been established along with the 12-weeks trial: 1) study information and screening; 2) day 0: start of the intervention; 3) day 28: group session (control group)/follow-up visit (Nutriprecision group); 4) day 56: group session (control group)/follow-up visit (Nutriprecision group) and 5) day 84: end of the intervention. At the start and finish days of the study, participants visited the Nutrition Intervention Unit or the Clinical Trials Unit in a fasting state. Participants were instructed to collect the first-morning urine sample. Additionally, volunteers from the University of Navarra self-collected fecal samples at baseline using OMNIgene.GUT kits from DNA Genotek. Volunteers were also informed of a digital-based procedure for cognitive assessment and other digital tools available depending on the assigned intervention (experimental VS control). Blood samples were drawn by venipuncture after a 12 h overnight fast in a clinical setting. After 10 minutes of rest and having answered the Mini Nutritional Assessment (MNA) and the Mini-Mental State Examination (MMSE) questionnaires, blood pressure was measured. Later, anthropometric measurements and body composition analysis were performed. Global cognitive performance was also assessed by the Guttmann NeuroPersonalTrainer platform. The duration of these visits was approximately 1 hour. On the 28th and 56th study days, participants assigned to the control group attended online group sessions and received intensive education and advice to increase the adherence to the dietary strategy. Sessions consisted of informative talks about the prescribed dietary pattern, food label use, seasonal shopping lists, meal plans and recipes, physical activity and exercise recommendations, sleep habits, etc. Contrary, participants allocated to the Nutriprecision group attended in person visits with the dieticians, to evaluate the adherence to the assigned nutritional treatment. Additionally, anthropometric, body composition, and blood pressure measurements were assessed. Participants were also asked to fill different questionnaires about health status (SF-36 Health Survey), gastrointestinal symptoms (gastrointestinal symptoms rating scale, GSRT), dietary assessment (7-day recall), Mediterranean diet adherence (14-Item Mediterranean Diet Assessment Tool), physical activity (International Physical Activity Questionnaire, IPAQ) and drug therapy modifications. Moreover, the Nutriprecision group were asked to collect a sensory perception questionnaire and a food consumption record of the precision foods administered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity
Keywords
Obesity, Health status, Insulin resistance, Hypertension, Lipid profile, Gastrointestinal health, Cognitive capacity, Life quality, Healthy ageing, Lifestyle intervention, Precision nutrition, Mediterranean diet, Eating behaviour, Physical activity, Oxidative stress, Inflammation, Functional ability, Nutrition education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants are randomly assigned to Control or NUTRIPRECISION strategy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control diet
Arm Type
Placebo Comparator
Arm Description
A conventional diet based on the current Spanish Mediterranean dietary guidelines: Spanish Society of Community Nutrition (SENC).
Arm Title
Nutriprecision diet
Arm Type
Experimental
Arm Description
A Mediterranean, balanced diet based on the inclusion of precision foods designed and developed within the framework of Nutriprecision project. A mobile application to empower and support the management of the dietary prescription. A digital tool for cognitive stimulation.
Intervention Type
Other
Intervention Name(s)
Control diet
Intervention Description
Control diet: A Mediterranean conventional diet based on the current dietary guidelines of the Spanish Society of Community Nutrition (SENC). Participants were strongly advised to use the Healthy Eating Plate (Harvard) to structure and prepare the main meals (lunch and dinner). In this way, at least ½ of the plate should be composed of vegetables, ¼ of lean protein, and ¼ of low glycemic index carbohydrates. The diet encourages participants to eat 5 times/day (breakfast, lunch, dinner, and two snacks). Overall, the control diet was based on high consumption of vegetables and fruits, whole grains, healthy fats (olive oil), and healthy proteins (legumes, fish, and lean meat). There was not energy restriction in the control diet.
Intervention Type
Other
Intervention Name(s)
Nutriprecision diet
Intervention Description
Nutriprecision diet: a Mediterranean balanced diet based on the inclusion of precision foods designed according to the particularities of the senior population. The selected precision foods were a) fruit compote, b) smoothie, c) extruded meat product, d) wholemeal bread, e) wholemeal biscuit and f) microwaveable deep-frozen vegetable products. The diet encourages participants to eat 5 times/day with a conventionally balanced distribution of macronutrients (50% of the total caloric value from carbohydrates, 20% from proteins, and 30% from lipids). There was not energy restriction, although the energy requirements of the participants were adjusted to a BMI of 25 kg/m2 to avoid an overestimate of calorie intake. A mobile application designed and developed to provide volunteers with information about follow-up visits, the assigned diet, recommendations, and messages to motivate them during the intervention. A digital tool for cognitive stimulation.
Primary Outcome Measure Information:
Title
Change From Baseline General Health Status at 3 Months
Description
General health score encompassed twelve parameters, on a scale of 0 to 21, with higher scores indicating a worse overall health: BMI Waist Circumference Glycosylated hemoglobin (HbA1C) Total cholesterol HDL-cholesterol LDL-cholesterol Triglycerides Uric acid Systolic Blood Pressure | Diastolic Blood Pressure Gastrointestinal Health (GSRT) Cognitive Function Extra negative point if reducing medication
Time Frame
0 months and 3 months
Secondary Outcome Measure Information:
Title
Change From Baseline Weight at 3 Months
Description
Weight was measured by a digital scale
Time Frame
0 months and 3 months
Title
Baseline height
Description
Height was recorded using a wall-mounted stadiometer (Seca 220, Vogel & Halke, Germany).
Time Frame
0 months
Title
Change From Baseline Body Mass Index at 3 Months
Description
Body mass index was calculated using the standard formula: weight (kg)/height (m)2
Time Frame
0 months and 3 months
Title
Change From Baseline Fat Mass at 3 Months
Description
Fat mass was measured by Bioelectrical impedance analysis (BIA, SC-330, Tanita)
Time Frame
0 months and 3 months
Title
Change From Baseline Lean Mass at 3 Months
Description
Lean mass was measured by Bioelectrical impedance analysis (BIA, SC-330, Tanita)
Time Frame
0 months and 3 months
Title
Change From Baseline Waist Circumference at 3 Months
Description
Waist Circumference was measured by with a tape measure
Time Frame
0 months and 3 months
Title
Change From Baseline Hip Circumference at 3 Months
Description
Hip Circumference was measured by with a tape measure
Time Frame
0 months and 3 months
Title
Change From Baseline Systolic Blood Pressure at 3 Months
Description
Systolic Blood Pressure was measured using an automatic monitor device (Intelli Sense. M6, OMRON Healthcare, Hoofdorp, the Netherlands)
Time Frame
0 months and 3 months
Title
Change From Baseline Diastolic Blood Pressure at 3 Months
Description
Diastolic Blood Pressure was measured using an automatic monitor device (Intelli Sense. M6, OMRON Healthcare, Hoofdorp, the Netherlands)
Time Frame
0 months and 3 months
Title
Change From Baseline Serum Triglycerides at 3 Months
Description
Triglycerides were measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Serum Total Cholesterol at 3 Months
Description
Total cholesterol was measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Serum LDL-Cholesterol at 3 Months
Description
LDL-cholesterol was measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Serum HDL-Cholesterol at 3 Months
Description
HDL-cholesterol was measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Serum Uric Acid at 3 Months
Description
Uric acid was measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Serum Glucose at 3 Months
Description
Glucose was measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Serum Insulin at 3 Months
Description
Insulin was measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Serum Glycosylated hemoglobin (HbA1C) at 3 Months
Description
Glycosylated hemoglobin (HbA1C) was measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Serum Aspartate Aminotransferase at 3 Months
Description
Aspartate aminotransferase was measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Serum Alanine Aminotransferase at 3 Months
Description
Alanine aminotransferase was measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Serum Gamma-glutamyltransferase at 3 Months
Description
Gamma glutamyltransferase was measured in fasting conditions
Time Frame
0 months and 3 months
Title
Change From Baseline Physical Activity Level at 3 Months
Description
Physical activity was measured by the International Physical Activity Questionnaire (IPAQ)
Time Frame
0 months and 3 months
Title
Change From Baseline Dietary Intake at 3 Months
Description
Dietary intake was measured by a 7-day recall
Time Frame
0 months and 3 months
Title
Change From Baseline Mediterranean Diet Adherence at 3 Months
Description
Mediterranean diet adherence was measured by the 14-Item Mediterranean Diet Assessment Tool
Time Frame
0 months and 3 months
Title
Change From Baseline Health Status at 3 Months
Description
Health status was measured by the SF-36 Health Survey
Time Frame
0 months and 3 months
Title
Change From Baseline Gastrointestinal Symptoms at 3 Months
Description
Gastrointestinal symptoms were measured by the gastrointestinal symptoms rating scale, GSRT
Time Frame
0 months and 3 months
Title
Change From Baseline Sensory Perception of Precision Foods at 3 Months
Description
Sensory perception of precision foods was measured by the sensory perception questionnaire
Time Frame
1 month and 3 months
Title
Food Consumption of the Precision Foods
Description
Food consumption of the precision foods was measured by a food consumption record
Time Frame
1 month, 2 months and 3 months
Title
Change From Baseline Risk of Malnutrition at 3 Months
Description
Risk of malnutrition was measured by the Mini Nutritional Assessment (MNA) questionnaire
Time Frame
0 months and 3 months
Title
Change From Baseline Cognitive Impairment at 3 Months
Description
Cognitive impairment was measured by the Mini-Mental State Examination (MMSE) questionnaire
Time Frame
0 months and 3 months
Title
Change From Baseline Cognitive Function at 3 Months
Description
Cognitive function was measured by the Guttmann NeuroPersonalTrainer platform
Time Frame
0 months and 3 months
Title
Baseline Gut Microbiota Composition
Description
Gut Microbiota Composition will be measured using OMNIgene.GUT kits from DNA Genotek
Time Frame
0 months
Title
Usability of the digital tools
Description
Usability will be measured using the System Usability Scale (SUS)
Time Frame
3 months
Title
Baseline subjective hunger
Description
Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification of the perceived hunger before the experimental food intake
Time Frame
Baseline
Title
Postprandial subjective hunger
Description
Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification of the perceived hunger measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Time Frame
Up to 120 minutes
Title
Baseline subjective fullness
Description
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived fullness before the experimental food intake
Time Frame
Baseline
Title
Postprandial subjective fullness
Description
Visual analogue scale rating in a scale from 0 to 100 mm, for the quantification of the perceived fullness measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Time Frame
Up to 120 minutes
Title
Baseline subjective satiety
Description
Visual analogue scale rating in a scale from 0 to100 mm for the quantification of the perceived satiety before the experimental food intake.
Time Frame
Baseline
Title
Postprandial subjective satiety
Description
Visual analogue scale rating in a scale from 0 to100 mm for the quantification of the perceived satiety measured at 15, 30, 45, 60, 90 and 120 minutes after experimental food intake
Time Frame
Up to 120 minutes
Title
Baseline subjective desire to eat
Description
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived desire to eat before the experimental food intake at baseline.
Time Frame
Baseline
Title
Postprandial subjective desire to eat
Description
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived desire to eat measured at 15, 30, 45, 60, 90 and 120 minutes after experimental food intake
Time Frame
Up to 120 minutes
Title
Baseline subjective thirst
Description
Visual analogue scale rating in a scale from 0 to 100 mm for the quantification of the perceived thirst before the experimental food intake at baseline
Time Frame
Baseline
Title
Postprandial subjective thirst
Description
Visual analogue scale ratings in a scale from 0 to 100 mm for the quantification the perceived thirst measured at 15, 30, 45, 60, 90 and 120 minutes after experimental food intake
Time Frame
Up to 120 minutes
Title
Baseline blood glucose concentration
Description
Blood glucose concentration before experimental food intake
Time Frame
Baseline
Title
Baseline blood insulin concentration
Description
Blood insulin concentration before experimental food intake
Time Frame
Baseline
Title
Incremental area under the curve (iAUC) for glucose
Description
The incremental area under the curve (AUCi) for glucose was calculated via the geometric sums of the areas of the triangles and trapezoids above the fasting glucose concentration over a 2-h period
Time Frame
0,15,30,45,60,90,120
Title
Incremental area under the curve (iAUC) for insulin
Description
The incremental area under the curve (AUCi) for insulin was calculated via the geometric sums of the areas of the triangles and trapezoids above the fasting insulin concentration over a 2-h period
Time Frame
0,15,30,45,60,90,120
Title
Baseline blood high density lipoprotein cholesterol (HDL) concentration
Description
Blood high density lipoprotein cholesterol (HDL) concentration before experimental food intake
Time Frame
Baseline
Title
Baseline blood low density lipoprotein cholesterol (LDL) concentration
Description
Blood low density lipoprotein cholesterol (LDL) concentration before experimental food intake
Time Frame
Baseline
Title
Baseline blood triglyceride concentration
Description
Blood triglyceride concentration before experimental food intake
Time Frame
Baseline
Title
Postprandial blood glucose concentration
Description
Blood glucose concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Time Frame
Up to 120 minutes
Title
Postprandial blood insulin concentration
Description
Blood insulin concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Time Frame
Up to 120 minutes
Title
Postprandial blood total cholesterol concentration
Description
Blood total cholesterol concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Time Frame
Up to 120 minutes
Title
Postprandial blood high density lipoprotein cholesterol (HDL) concentration
Description
Blood high density lipoprotein cholesterol (HDL) concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Time Frame
Up to 120 minutes
Title
Postprandial blood low density lipoprotein cholesterol (LDL) concentration
Description
Blood low density lipoprotein cholesterol (LDL) concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Time Frame
Up to 120 minutes
Title
Postprandial blood triglyceride concentration
Description
Blood triglyceride concentration measured at 15, 30, 45, 60, 90 and 120 minutes after the experimental food intake
Time Frame
Up to 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged 50-80 years BMI >27 kg/m2 One or more of the following risk factors: Glucose ≥100 to ≤125 mg/dL or type 2 diabetes (independently of antidiabetic medication) Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg or under antihypertensive medication) LDL-cholesterol ≥160 mg/dL independently of lipid-lowering therapy HDL-cholesterol ≤40 mg/dL (men)/≤50 mg/dL (women), independently of lipid-lowering therapy Triglycerides ≥160 mg/dL independently of lipid-lowering therapy Waist Circumference ˃95 cm (men)/>82 cm (women), independently of lipid-lowering therapy Sedentary behavior (AHA)* Exclusion Criteria: Relevant functional or structural digestive abnormalities (malformations, angiodysplasia, active peptic ulcers, chronic inflammatory diseases, or malabsorption) Endocrine disorders (hyperthyroidism or uncontrolled hypothyroidism) Undergone surgical interventions with permanent sequelae (gastroduodenostomy) Pharmacological treatments with immunosuppressants, cytotoxic agents, systemic corticosteroids, or other drugs that could potentially cause hepatic steatosis or alteration of liver tests Active cancer in the last five years or under therapy Weight loss ≥3 kg in the last three months Instable drug therapy in the last three months Severe psychiatric disorders No autonomy Inability to follow the diet (food allergies, intolerances) Difficulties to follow scheduled visits AHA Recommendations for Physical Activity in Adults: at least 150 minutes per week of moderate-intensity aerobic activity or 75 minutes per week of vigorous aerobic activity, or a combination of both, preferably spread throughout the week.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itziar Abete Goñi, PhD
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Santiago Navas Carretero, PhD
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M Ángeles Zulet Alzórriz, Professor
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carlos Javier González Navarro, PhD
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
J. Alfredo Martínez Hernández, Professor
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Viviana Loria Kohen, PhD
Organizational Affiliation
IMDEA Food
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Ramirez Molina, PhD
Organizational Affiliation
IMDEA Food
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Guillermo Reglero Rada, Professor
Organizational Affiliation
IMDEA Food
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elena Aguilar Aguilar, PhD
Organizational Affiliation
IMDEA Food
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helena Marcos Pasero
Organizational Affiliation
IMDEA Food
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susana Molina
Organizational Affiliation
IMDEA Food
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carmen Crespo
Organizational Affiliation
IMDEA Food
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cristina Galarregui Miquelarena
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Blanca Martínez de Morentín, MD
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Salomé Pérez Díez
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
María Hernández Ruiz de Eguilaz
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Veronica Ciaurriz Fernández
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
María Zabala Navó
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Begoña de Cuevillas García
Organizational Affiliation
Centre for Nutrition Research - University of Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
José Manuel Iniesta Chamorro
Organizational Affiliation
Universidad Politécnica de Madrid (UPM)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paloma Chausa Fernández
Organizational Affiliation
Universidad Politécnica de Madrid (UPM)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
José Tapia Galisteo
Organizational Affiliation
Universidad Politécnica de Madrid (UPM)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elena Hernando Pérez
Organizational Affiliation
Universidad Politécnica de Madrid (UPM)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Enrique J. Gómez Aguilera
Organizational Affiliation
Universidad Politécnica de Madrid (UPM)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alexis Álvarez Rollán
Organizational Affiliation
Grupo I.C.A. Informática y Comunicaciones Avanzadas, S.L.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alejandro García Rudolph
Organizational Affiliation
Institut Guttmann, University Institute attached to the Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain; Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain; The Health Sciences Research Institute of the Germans
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alberto García Molina
Organizational Affiliation
Institut Guttmann, University Institute attached to the Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain; Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain; The Health Sciences Research Institute of the Germans
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Josep Maria Tormos Muñoz
Organizational Affiliation
Institut Guttmann, University Institute attached to the Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain; Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain; The Health Sciences Research Institute of the Germans
Official's Role
Study Chair
Facility Information:
Facility Name
Centre for Nutrition Research, University of Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28829397
Citation
de Toro-Martin J, Arsenault BJ, Despres JP, Vohl MC. Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. Nutrients. 2017 Aug 22;9(8):913. doi: 10.3390/nu9080913.
Results Reference
background
PubMed Identifier
31601025
Citation
Gonzalez-Muniesa P, Martinez JA. Precision Nutrition and Metabolic Syndrome Management. Nutrients. 2019 Oct 9;11(10):2411. doi: 10.3390/nu11102411.
Results Reference
background
Citation
Brooke, JB (1996). SUS - a quick and dirty usability scale. In: Usability Evaluation in Industry, Jordan, P, Thomas, B, Weerdmeester, B, and McLelland, I(eds), Taylor and Francis: London
Results Reference
background

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Precision Nutrition Strategies for Improving the Quality of Life of Pre-senior and Senior Populations

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